Recall Z-1012-2017— Symmetry Surgical, Inc.

Name: FDA recall Z-1012-2017
Creator: U.S. Food and Drug Administration
Published: 2016-11-29

Class II · Terminated

Class II FDA medical device recall by Symmetry Surgical, Inc., initiated 2016-11-29, terminated 2017-08-20. It names one FDA 510(k) clearance: K113776. Product: symmetry surgical ULTRA(R) Gravity container, REF numbers: C131310-G, C13134-G, C13135-G, C13136-G, C13139-G, C13854-G, C13855-G, C13856-G, C181310-G, C18134-G, C18135-G, C18136-G, C18138-G, C22854-G, C22855-G, C22856-G, C22858-G, C24134-G, C24135-G, C24136-G, C24138, C24138-G Product Usage: sterilization container. Reason: Sealant on the base trim of sterilizer container may be deteriorated or absent which could provide a path for contaminants to enter the container under certain conditions post-sterilization..

Recalling firm: Symmetry Surgical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-11-29
Terminated: 2017-08-20
Firm location: Antioch, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K113776 — FLASHPAKSymmetry Medical·cleared 2012-08-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

symmetry surgical ULTRA(R) Gravity container, REF numbers: C131310-G, C13134-G, C13135-G, C13136-G, C13139-G, C13854-G, C13855-G, C13856-G, C181310-G, C18134-G, C18135-G, C18136-G, C18138-G, C22854-G, C22855-G, C22856-G, C22858-G, C24134-G, C24135-G, C24136-G, C24138, C24138-G Product Usage: sterilization container

Reason for recall

Sealant on the base trim of sterilizer container may be deteriorated or absent which could provide a path for contaminants to enter the container under certain conditions post-sterilization.

Data sourced from openFDA. This site is unofficial and independent of the FDA.